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To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.
This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.
Tertiary care hospitals across metropolitan areas in India.
Adult trauma patients and residents managing these patients were included.
ATLS or PTC training was provided for residents in the intervention arms.
The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.
Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.
Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.
Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.
Retrospective and prospective cohort study.
Secondary care RDC in London.
Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.
The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.
Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).
Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.
Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.
The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.
This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.
The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.
CTRI/2024/01/061975 (Registered on: 29 January 2024).
Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.
The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.
The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.
To describe the development and refinement of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice through stakeholder feedback. The tool, based on the Fundamentals of Care Framework, supports healthcare leaders and clinicians in assessing fundamental care in a practical and user-friendly manner that embraces rather than minimises the inherent complexity of this care delivery as it occurs in practice.
Multi-method study informed by participatory action principles.
Data collection involved an anonymous online survey and cognitive interviews with key stakeholders internationally to gauge perspectives on the clarity, usability, and acceptability of the tool. Data were collected between October–December 2023. Quantitative, categorical data were analysed using descriptive statistics. Qualitative data were analysed via content analysis.
Participants described the Tool as Comprehensive, Practical, and Useful. Participants liked the visual representation of results in the form of bar and radar diagrams, which aided in interpreting the outcomes. The main suggestions for improvement were: (1) Simplifying items relating to the ‘Context of Care’ dimension of the Fundamentals of Care Framework; (2) Reducing similarity between some items; (3) Separating or simplifying items with multiple components; and (4) Clarifying terminology.
Based on stakeholder feedback, the Flinders Fundamentals of Care Assessment Tool for Clinical Practice is now digitised and includes a comprehensive instruction manual and definitions for each element of the Fundamentals of Care Framework assessed within the tool. The tool supports healthcare leaders and clinicians to assess fundamental care delivery at multiple levels—individual, team, unit/ward, organisational—identifying areas of strength and improvement to inform decision-making, planning, and quality improvement. The tool offers a way of assessing fundamental care holistically as a multi-dimensional construct rather than as a series of disaggregated tasks, better reflecting and capturing the complex reality of fundamental care delivery.
The Flinders Fundamentals of Care Assessment Tool for Clinical Practice supports real-time feedback (i.e., immediate visualisation of results), facilitating its integration in clinical practice to support enhanced fundamental care delivery.
Seeking stakeholder feedback has enhanced the relevance, acceptability, and feasibility of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice, facilitating its use as a decision-making and planning tool to support improved fundamental care delivery across clinical settings.
This study is reported using the CROSS and SRQR guidelines.
No Patient or Public Contribution.
The Fundamentals of Care (FoC) Framework emphasises that care quality depends not only on clinical tasks but also on interpersonal relationships and the organisational context in which care is delivered. Although patient-reported outcome and experience measures (PROMs and PREMs) have gained relevance in capturing these aspects, tools based on the FoC Framework remain limited in non-English-speaking settings.
To psychometrically validate the Spanish version of the FoC Intelligence Modelling Tool (FoC-IMT) and explore predictive relationships among the FoC dimensions: Context, Relationship and Integration of Care.
A cross-sectional study was conducted with 1053 hospitalised patients in southern Spain. Exploratory and confirmatory factor analyses (EFA and CFA) were performed, alongside a mediation analysis using partial least squares structural equation modelling (PLS-SEM) to examine directional relationships among constructs.
EFA and CFA supported a two-factor model—Context and Integration of Care—with excellent internal consistency (Cronbach's α and McDonald's ω = 0.97). CFA showed a moderate correlation between these factors. However, PLS-SEM mediation analysis revealed a directional model in which Context influences Relationship (β = 0.39), which in turn predicts Integration of Care (β = 0.89). Although embedded within Integration under CFA, the Relationship showed independent predictive power in PLS-SEM, validating its conceptual importance. This aligns with the foundational assumption of the FoC Framework: that caregiving quality is shaped not only by tasks or procedures but by the broader environment and interpersonal relationships in which care occurs.
The Spanish FoC-IMT Tool is a valid, reliable instrument for assessing person-centred care. The predictive model highlights the pivotal role of therapeutic relationships in delivering integrated, high-quality care.
Hospitalised patients contributed directly by responding to the FoC-IMT survey, thereby shaping the psychometric validation and predictive model. Patients were not involved in the study design, conduct or manuscript preparation.
by Karina Kouzaki, Mako Isemura, Yuki Tamura, Hiroyuki Uno, Shunta Tadano, Ryuji Akimoto, Katsu Hosoki, Koichi Nakazato
Cancer cachexia causes severe muscle wasting, and current treatments remain limited. Belt-type electrical muscle stimulation (bEMS) has emerged as a passive rehabilitation tool capable of activating multiple lower limb muscles simultaneously. We investigated whether bEMS prevents muscle wasting and improves functional outcomes in rats with cancer cachexia. Cancer cachexia was induced in male Sprague-Dawley rats by intraperitoneal injection of AH130 Yoshida hepatoma cells. Acute and chronic effects of bEMS were tested. Muscle protein synthesis was evaluated using the SUnSET method, and muscle fiber cross-sectional area (CSA) and ankle torque were measured after chronic stimulation. bEMS increased puromycin-labeled protein levels on day 3 post-injection (~1.5–2.0 fold; pAs of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.
We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.
A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.
There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).
Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.
In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.
The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.
ClinicalTrials.gov NCT04408495.
During the first wave of the COVID-19 pandemic, there was a notable decline in emergency department (ED) usage in many jurisdictions. This study assessed changes in ED use during this period and explored how the pandemic may have aggravated existing healthcare access inequities.
Our primary objective was to assess pandemic-related changes to ED visits and emergency hospitalisations for distinct demographic groups.
We conducted a retrospective observational study using population-based provincial administrative data.
We analysed data from all the 109 EDs and urgent care centres in Alberta, Canada, during the first wave of the COVID-19 pandemic (15 March 2020 to 30 June 2020), and during the corresponding (control) period 1 year earlier. We conducted subgroup analyses by age, First Nations status, sex, location and material deprivation. We repeated all analyses for pre-selected life-threatening emergency diagnoses.
We examined outcomes for a priori subgroups, including female and ‘other’ sex patients, paediatric patients (age 0–17 years), seniors (age 65 years and older), patients living in remote areas (greater than 200 km from an urban centre), First Nations members and patients living in materially deprived postal codes falling into the two most deprived Pampalon Index quintiles.
Primary outcomes were number of ED visits, number of ED visits with admission to hospital and number of ED visits resulting in patient death in the ED. A secondary outcome was change in ED use for life-threatening diagnoses (eg, cardiac conditions and hepatic disease).
ED visits in the COVID-19 period decreased by 34% (Poisson means test p
Reductions in critical emergency care and emergency hospital admissions were unequally distributed across demographic groups during the COVID-19 period. Study methods could be used to monitor and support equitable access to emergency care among distinct populations.
The McMaster Monitoring My Mobility (MacM3) study aims to understand trajectories of mobility decline in later life using multisensor wearable technology. To our knowledge, MacM3 is the first major cohort to combine accelerometry and a Global Positioning System (GPS) to track real-world mobility in community-dwelling older adults.
Between May 2022 and May 2024, MacM3 recruited 1555 community-dwelling older adults (mean age 73.9 years, SD=5.5) from Hamilton and Toronto, Ontario. Of the cohort, 68.4% were female, 62.4% married/partnered, 75.3% had post-secondary education and 62.9% had≥3 comorbidities. Most were Canadian born (69.4%) and white/Caucasian (88.0%), with greater ethnocultural diversity observed at the Toronto site.
At baseline, 56.7% of participants reported no mobility limitations, 15.9% had preclinical limitations and 27.4% had minor mobility limitations. Mean gait speed for the total sample was 1.23 m/s, with a mean Timed Up and Go time of 9.4 s and a 5x sit-to-stand time of 13.0 s. A total of 1301 participants had valid wrist-worn device data, and 1008 participants who agreed to wear the thigh-worn device had valid data (≥7 days with ≥10 hours of wear per day). Step count data (n=1008) revealed a mean of 8437 steps per day (SD=2943), with 5073 steps in the lowest quartile and 12 303 steps in the highest.
Ongoing work aims to develop predictive models of mobility decline by integrating wearable, clinical and environmental data. Pipeline enhancements will enable GPS/inertial measurement unit fusion to explore mobility-environment interactions and support ageing-in-place tools.
Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.
UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).
This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.
Type 1 diabetes (T1D) demands self-management skills, knowledge and confidence to prevent medical complications. Adolescents living with T1D have distinct developmental challenges resulting in a worsening in glycaemic stability, irregular care and an increased risk for complications all while transitioning to adult healthcare. Age-specific online platforms could facilitate transition by fostering self-management education and support. The Support online self-guided training platform has been shown to increase the confidence of adults with T1D in managing their glycaemia. We aim to test the effectiveness of Support-t (ie, adapted for youth), compared with usual care, in improving haemoglobin A1c (HbA1c) and to understand the context of its implementation.
We will conduct a multisite, assessor-blinded, randomised controlled, parallel group, two-arm, superiority trial, evaluating effectiveness and implementation of Support-t versus usual care in 200 adolescents (14–16 years old) living with T1D. The active arm will have an 18-month access to Support-t, and their healthcare team will be trained on the platform’s content. The control arm will receive usual care. The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes-specific quality of life, diabetes distress, continuous glucose monitoring metrics, number of severe hypoglycaemic events, diabetic ketoacidosis, T1D-related emergency department visits and hospitalisations as well as engagement and satisfaction. A subgroup of participants in the active arm and of healthcare providers will be interviewed assessing barriers, facilitators, engagement and fidelity of the intervention. Primary analysis will be by intention-to-treat. The difference in mean HbA1c at 18 months (with a 95% CI) will be calculated between both arms. A cost-effectiveness analysis is also planned.
December 8, 2024 version of the protocol was approved by the McGill University Health Centre Research Ethics Board (MP-37-2024-9734). Results will be disseminated through peer-reviewed publications and patient-partners’ network.
ClinicalTrials.gov (NCT05910840).
As the HIV epidemic stabilises in Sub-Saharan Africa with effective antiretroviral therapy, cardiometabolic disorders (CMDs) remain the next major challenge for people living with HIV. Relationship dynamics and spousal support are important for the medical management of single diseases such as HIV, yet little is known about how couples manage the complexity of multiple competing health conditions and their synergistic effects on health. The Healthy Hearts study aimed to develop a conceptual model of dyadic management of HIV and CMDs, inform interventions for couples in Sub-Saharan Africa, and ultimately improve clinical practice and disease management for HIV and CMD comorbidities.
This study will enrol 250 couples who have at least one partner living with HIV and CMD (either hypertension or diabetes) for a prospective observational cohort study. Patients will be recruited from HIV and CMD clinics in Zomba and Blantyre, Malawi. Couples will attend four study visits at quarterly intervals over 12 months. Both partners are given interviewer-administered surveys and complete a clinical assessment. Regression techniques will be used to test associations between key constructs in our conceptual model, including communal coping, multimorbidity illness perceptions, relationship quality, psychosocial health, disease management (eg, adherence to lifestyle advice and medications) and disease outcomes (eg, viral suppression and CMD control). Findings will be used to identify elements to target in a couple-based intervention for CMD and HIV.
This study was approved by the University of California, San Francisco (HRPP (Human Research Protection Program); Protocol number 20–32126), and the National Health Sciences Research Committee of Malawi (Protocol number 21/04/2677). The results will be disseminated at local community meetings and conferences focused on relationships, CMDs and HIV and published in scientific journals.
Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.
The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.
This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.
This study aimed to investigate the association between food insecurity and dietary intake with anxiety and depression among residents of underserved urban settlements in Bangladesh.
This cross-sectional study was used to collect data from participants through face-to-face interviews using structured questionnaires. Food security status was assessed using the Household Food Insecurity Access Scale, while anxiety and depression levels were measured using the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9, respectively. Dietary intake was evaluated through a 24-hour dietary recall and Food Frequency Questionnaire method.
Five districts located within the Khulna Division of Bangladesh.
Residents of underserved urban areas in Bangladesh (n=749), aged ≥18 years old.
Results indicated that 22.1%, 74.6% and 44.5% of participants experienced severe food insecurity, mild to moderate food insecurity and low Household Dietary Diversity Score, with a significant portion also showing symptoms of anxiety (57.1%) and depression (57.9%). Food insecurity and Household Dietary Diversity Score were found to be positively associated with both anxiety (p
These findings highlight that food insecurity not only affects dietary habits but also exacerbates mental health outcomes. Addressing food insecurity and balanced dietary intake could therefore contribute to better mental health outcomes and overall well-being in underserved communities. Policymakers should prioritise comprehensive strategies that ensure access to nutritious foods and provide mental health support to vulnerable groups.
Introducción. La punción arterial para el análisis gasométrico provoca dolor de intensidad variable. Este dolor podría alterar la dinámica ventilatoria y, por tanto, los parámetros respiratorios de la muestra sanguínea. Objetivos. Determinar la posible relación entre el dolor inducido por la punción arterial y los parámetros obtenidos del análisis gasométrico de estas muestras de sangre. Como objetivos secundarios, obtener la prevalencia del dolor provocado en la muestra estudiada y la posible asociación con el número de intentos. Metodología. Estudio transversal que incluyó 100 muestras arteriales de 61 pacientes durante el primer semestre de 2024. La intensidad del dolor, reportada mediante la escala NRS-11, fue la variable principal de estudio. Se analizó la asociación de esta variable con variables gasométricas (por ejemplo, pH, pO2, pCO2 y lactato) y con otras variables sociodemográficas y relacionadas con punción arterial. Resultados. La edad fue de 69,43 ± 13,07 y el 68% eran hombres. Respecto a la variable principal de resultado, la puntuación media del dolor fue de 4,03 ± 2,61. La intensidad del dolor no mostró asociación con ninguna variable gasométrica. Sin embargo, el número de intentos de obtener con éxito una muestra arterial mostró significación. Tras ajustar por otras variables, cada intento adicional aumentaba el dolor en 1,14 puntos. Discusión. No se encontró asociación entre el dolor de la punción arterial y los parámetros del análisis gasométrico, por lo que los resultados pueden interpretarse de forma robusta en situaciones en las que no es posible un manejo adecuado del dolor.
ABSTRACT
Introduction. Arterial puncture for gasometrical analysis causes pain of varying intensity. This pain could alter the ventilatory dynamics and therefore the respiratory parameters of the blood sample. Objectives. To determine the possible relationship between the pain induced by arterial puncture and the parameters obtained from the gasometrical analysis of these blood samples. As secondary objectives, to obtain the prevalence of pain caused in the sample studied and the possible association with the number of attempts. Methodology. Cross-sectional study involving 100 arterial samples from 61 patients during the first half of 2024. Pain intensity reported by the NRS-11 was the main study variable. The association of this variable with gasometrical variables (for example: pH, pO2, pCO2, lactate) and with other variables of different nature (sociodemographic and related to the arterial puncture itself) was analyzed. Results. The age was 69,43 ± 13,07 and 68% were men. Regarding the main outcome variable, the mean pain score was 4.03 ± 2.61. Pain intensity showed no association with any of the gasometric variables. However, the number of attempts to successfully obtain an arterial sample showed significance. After adjustment for other variables, each additional attempt increased pain by 1.14 points. Discussion. No association was found between arterial puncture pain and gasometric analysis parameters, so the results can be robustly interpreted in situations where adequate pain management is not possible.
Older adults may experience a wish to die in the context of deteriorating health, a loss of autonomy, loneliness, or depression. Home care workers may likewise experience burden or symptoms of depression as a result of prolonged contact with this physical and emotional suffering. Training initiatives that can support the well-being of home care workers are therefore important.
To describe the typical profile of older adults who express a wish to die to their home care worker, and to examine whether a psycho-educational intervention for care workers exploring the end-of-life process and self-care strategies had an impact on the older adult's wish to die and on the care worker's perceived burden and depressive symptoms.
Quasi-experimental, longitudinal study involving non-randomized experimental and control groups and follow-up at 3–6 months post-intervention.
At the start of the study, all care workers (n = 126) provided sociodemographic information (age, gender) for themselves and the care recipient, and completed the Karnofsky Performance Status scale and the Assessment of the Frequency and Extent of the Desire to Die (AFEDD) interview to provide a baseline measure of the care recipient's functional status and wish to die. They also completed the Beck Depression Inventory (BDI) and Zarit Burden Interview (ZBI) as a measure of their own perceived burden and depressive symptoms. The AFEDD, BDI, and ZBI were completed again by care workers at 3 and 6 months post-intervention.
The typical profile of care recipients was a woman aged 85.5 years who required considerable support and assistance and who had at least occasionally experienced a wish to die, although these thoughts were not always verbalized. Scores on the AFEDD remained relatively stable over the follow-up period in both the control and experimental groups. There was no significant association between the older adult's wish to die and depressive symptoms in the care worker across the study period. However, a positive and significant correlation between a wish to die in the older adult and perceived burden in the care worker was observed at 6 months post-intervention in both the total sample (p = 0.032) and among controls (p = 0.028). By contrast, this significant association was not found for care workers in the experimental group (p = 0.376), suggesting that the psycho-educational intervention may have had a protective effect.
Although further studies are needed to corroborate and extend these findings, the results suggest that psycho-educational interventions aimed at increasing home care workers' understanding of the end-of-life process and which introduce them to self-care strategies may help to reduce their perceived burden when the older person for whom they are caring expresses a wish to die.
Home care workers may find it challenging to care for an older adult who expresses a wish to die. Psycho-educational interventions that enhance care workers' understanding of the end-of-life process and teach them self-care strategies could help to support their well-being and their ability to provide adequate care.
There is evidence that talking about the end of life with patients facing a life-threatening disease is not upsetting, and in fact, it may even be beneficial. However, both patients and health professionals can find it difficult to engage in these conversations. The aim of this clinical trial is to explore whether proactively inviting people with advanced cancer to share their thoughts about death and dying is distressing for them, comparing the impact with usual clinical practice (ie, a reactive approach to these issues).
A stepped-wedge cluster randomised controlled trial involving six palliative care units in Spain will be conducted. Each unit will recruit participants for both the experimental and control groups. Units will be randomised to determine the order in which they will begin implementing the intervention: GO-TaD (Give the Opportunity to Talk about Death thoughts). The trial will involve six sequences and seven periods (steps), with four patients per period (patients in each period will be different). The primary outcome will be emotional distress, assessed with the Detecting Emotional Distress scale. The following secondary variables will also be analysed: hopelessness, using the Beck Hopelessness Scale; quality of the patient–professional relationship, with the Patient–Doctor Relationship Questionnaire (PDRQ-9); and quality of life, with the Palliative Outcome Scale . The trial will follow the CONSORT extension for stepped-wedge cluster randomised designs. The primary analysis will include all eligible patients, applying mixed-effects regression models for binary results and mixed linear models for continuous data. Results will be reported as risk differences and ORs, with 95% confidence intervals. Analyses by sub-groups of interest (eg, age, gender, type of palliative care unit) will also be conducted. All analyses will be performed using R.
Ethical approval has been obtained from the researchers' university and all participating centres. Results will be disseminated through peer-reviewed open access publications, academic conferences and presentations to clinical audiences.
NHS 111 Wales offers 24-hour telephone assessment, care and referrals for urgent healthcare needs. Call handlers use the newly created and implemented Call Prioritisation Streaming System (CPSS) to assess patients. CPSS is a sophisticated Computer Decision Support Software designed to enhance decision-making processes. It achieves this by integrating individual patient data with a comprehensive computerised knowledge base, employing advanced software algorithms to produce recommendations and dispositions.
While CPSS offers many advantages, its introduction marked a major shift in clinical digital processes. Because of this significant change, it was essential to ensure that the system was functioning correctly and safely after it was implemented. This process of verification and validation is known as postimplementation clinical assurance.
An adapted Delphi–Rand/UCLA appropriateness method assessed patient outcomes. In round 1, 189 random anonymised cases were reviewed by international expert clinicians from diverse clinical backgrounds, with consensus measured at
In round 1, 49 participants reviewed all 189 cases (total 9913 reviews). In round 2, 41 participants continued to review (total 1746 reviews). Consensus on outcome appropriateness was achieved in 83% (7726 reviews of 144 cases), with a range of 100–76%. Non-consensus occurred in 16.6% (1535 reviews of 45 cases), with a range of 73–18%. For cases with consensus, participants agreed with the outcome 90.5% of the time; for non-consensus cases, outcome agreement was still 60.9%.
Content analysis highlighted the complex interplay of clinician-added value and the aims of prioritisation and streaming. Three themes to enhance CPSS were identified: clinical considerations, referral pathways and system-driven safeguarding identification. No significant clinical safety concerns were found.
The evaluation of CPSS in NHS 111 Wales shows high levels of outcome appropriateness, assuring patients, service providers and stakeholders. CPSS effectively prioritises and streams patients to appropriate outcomes based on expert clinician consensus.
FreshRSS 